Yonsei Med J.
2022 Jan;63(S1):56-62. 10.3349/ymj.2022.63.S56.
Survey for Government Policies Regarding Strategies for the Commercialization and Globalization of Digital Therapeutics
- Affiliations
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- 1Department of Public Health, Yonsei University Graduate School, Seoul, Korea.
- 2Institute of Health Services Research, Yonsei University, Seoul, Korea.
- 3Department of Preventive Medicine, Gachon University College of Medicine, Incheon, Korea.
- 4Center for Public Healthcare, Gachon University Gil Medical Center, Incheon, Korea.
- 5Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Korea.
- 6Department of Medical Device Engineering and Management, Yonsei University Graduate School, Seoul, Korea.
- 7Health IT Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
- KMID: 2524804
- DOI: http://doi.org/10.3349/ymj.2022.63.S56
Abstract
- Purpose
This study was conducted to build a direction for government policies regarding strategies for the commercialization of digital therapeutics in Korea, as well as its globalization.
Materials and Methods
The study included 37 participants from the Korea Digital Health Industry Association (KODHIA). The data was based on a survey conducted in 2020 targeting employees of companies engaged in the digital health industry in Korea. Participants were asked about their involvement in product development of digital therapeutics and their opinion about the growing motivator for digital therapeutics in Korea and the global market.
Results
According to our data, among subjects not involved in making digital therapeutics products, the main reason for not being involved was the lack of experts (73.9%) and difficulty in licensing (73.9%). Responses concerning the priority area in need of national support were R&D funding (43.2%), and the next was licensing guidance and simplifying regulations (24.3%). Possible difficulties of overseas market expansion were the unfamiliarity in digital therapeutics technology verification and licensing structures of foreign countries (73%), and concerns regarding the level of recognition of clinical trials and technology in Korea from overseas (70.3%). Overall, respondents were hesitant in starting a related business due to the lack of government support and the complexity of the regulation process. Moreover, concerns about global market entry were similar. Being unfamiliar with the novel process and worrying about the achievement despite existing challenges were the biggest drawback.
Conclusion
For the digital therapeutics industry to evolve domestically and internationally, government support and guidance are essential.
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